Vital Signs— 510(k) K251200
Substantially EquivalentOxehealth Limited
FDA 510(k) clearance K251200 for Vital Signs, Substantially Equivalent on 2026-02-02. Applicant: Oxehealth Limited. Device class: 2.
Summary
Oxehealth's device is named only Vital Signs and is filed under product code QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate). The name is generic, and the record doesn't describe the software further.
Class II, 21 CFR 870.2785. Cardiovascular is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Oxehealth filed from Abingdon, United Kingdom. The decision came 290 calendar days after FDA received it (April 18, 2025 to February 2, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Oxehealth Limited
- Product code
- Product code QME
- Device class
- Class 2
- Regulation
- 21 CFR 870.2785
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Abingdon, GB
Recent devices under product code QME
view allMore clearances from Oxehealth Limited
view allData sourced from openFDA. This site is unofficial and independent of the FDA.